Project Process Engineer, 1st Shift
Company: Hikma Pharmaceuticals PLC
Location: Cherry Hill
Posted on: March 9, 2023
Job Description:
Responsible for the conceptual and detailed development of
project scopes and processes in a cGMP sterile injectable facility.
This includes aspects of project management such as obtaining
funding for capital engineering improvements to the plant and
production equipment, coordinating design efforts while utilizing
reliability engineering concepts as the foundation of design,
managing document approvals, and coordinating the procurement,
construction, installation, start-up, and commissioning of up to
twenty projects simultaneously. The engineer also provides
technical support to production, QA, and validation.
- Regular and predictable onsite attendance and punctuality.
- Responsible for project management of assigned projects.
- Prepare project scopes, processes, and specifications:
- Meet the objectives of the process owner and are
compliant;
- Are mechanically and financially feasible;
- Meet all code and safety requirements;
- Are completed within time frame assigned by management.
- Obtain necessary project funding by preparing RFQ's and CPA's
as required:
-
-
- Provide adequate funding to meet the objectives of the project.
- Track and expedite funding to meet the project timelines.
- Projects under $1,000,000 - manage projects with oversight of
Senior Engineers & Engineering Management:
- Coordinate work between engineering or engineering firm,
client, vendors, and contractor;
- Ensure that all compliance, code, safety, security, and permit
requirements are met;
- Manage project costs, including field changes, within
budget;
- Meet all scope requirements.
- Meet project timelines.
- Projects over $1,000,000: Assist Senior Engineers & Engineering
Management.
-
-
- Submit all pertinent data to Hikma Engineering Services.
- Provide liaison support between client, plant services, and
Hikma Engineering to ensure full compliance to GMP requirements
including design, installation, startup, commissioning, and
validation.
- Provide general engineering assistance to senior engineers &
engineering management on a timely basis. This includes:
- Studies, plans, and cost estimates;
- Previous capital installations;
- Other departments requesting engineering support;
- Establishing and implementing project engineering management
and compliance systems Improvements;
- The administration of reliability engineering in relation to
production systems. QUALIFICATIONS
- Minimum: B.S Engineering
- Preferred: Professional Engineering license is a plus
EXPERIENCE
- Minimum: Two to ten years of engineering experience in the
pharmaceutical/biotech industry SKILLS
- The applicant must have a working knowledge of cGMPs as they
relate to sterile pharmaceutical manufacturing
- Demonstrated knowledge of pharmaceutical facilities and
production equipment, inclusive of their design, installation, and
operation
- Individual must also demonstrate the ability to use project
management techniques and tools in the management of multiple
engineering projects
- Knowledge of contracting/vendor selection and applicable
codes
- Familiarity with the latest in pharmaceutical manufacturing
equipment and facilities
- Working knowledge of ISPE Baseline Engineering Guidelines
- Proficiency with Microsoft Office and familiarity with
AutoCAD
Location:
Keywords: Hikma Pharmaceuticals PLC, Cherry Hill , Project Process Engineer, 1st Shift, Engineering , Cherry Hill, New Jersey
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